Complying with new CMS Preventive Maintenance Regulations

DPA Insights
By Steve Mueller, Director of Operations

Why Reliability Risk Assessments Are Essential

It’s a no-brainer that hospitals’ critical medical equipment be regularly evaluated and maintained. But medical equipment is just one of many elements in any hospital’s pursuit of quality, effectiveness and positive patient experiences.

But what happens to this Triple Aim when a hospital’s HVAC system isn’t working at its best? Or when backup generators fail after a power outage? Or security goes down? Or the inventory system doesn’t accurately project future needs?

The latest Centers for Medicare & Medicaid Services (CMS) regulations for Preventive Maintenance, §482.41(c)(2) require that hospitals “make adequate provisions to ensure the availability and reliability of equipment needed for its operations and services.”

Preventive Maintenance RegulationsThe CMS sets minimum standards for preventive maintenance tasks on outside manufacturers’ (OEM) non-medical equipment. However, an OEM’s maintenance program doesn’t always guarantee reliability. How equipment is used, the environment it operates in, and the quality of parts and materials used to build or repair it can vary from hospital to hospital.

Given these variations in how non-medical equipment is built, installed, operated, serviced and repaired, how can hospitals better ensure its reliability? One strategy is to conduct a Reliability Risk Assessment. This can be conducted in house or contracted out to a reliability consultant if the necessary skills are unavailable.

A reliability risk assessment includes a failure mode, effect, and criticality analysis (FMECA) or related analytical tools, an analysis of maintenance records to understand repair history and a visit to the equipment’s location to understand its operating environment. To get insight into each piece of equipment’s performance, FMECA should include discussions with equipment users or technicians who service it.

The FMECA analysis should yield a maintenance strategy—down to the component level—that indicates the maintenance tasks and schedules that are needed to achieve 99% or better reliability.

The FMECA risk assessment may recommend several types of maintenance strategies that contribute the most to reliability. These include Preventive Maintenance (time-based maintenance), Predictive Maintenance (condition-based maintenance), Reactive Maintenance (corrective, breakdown or run-to-failure maintenance) or Reliability-Centered Maintenance (a maintenance strategy that not only considers equipment condition, but also considers other factors unique to individual pieces of equipment, such as equipment function, consequences of equipment failure, and the operational environment).

The CMS cautions against reducing the frequency of preventive maintenance activities. Your hospital may discover that the frequency needs to be increased or that preventive maintenance tasks you perform on OEM equipment should be modified to further reduce the risk of failure. If your situation is significantly different that an OEM’s ‘typical’ usage profile and environment, the maintenance effort should be adjusted. All changes that hospitals make to an OEM’s maintenance recommendations must be fully documented and reviewed by the hospital’s clinical maintenance and/or safety department personnel.

It is not enough to simply comply with the letter of the CMS regulations. A reliability risk assessment provides the information to meet the spirit of the regulations which is to ensure an acceptable level of safety and quality for a hospital’s staff and patients.

What have your hospital’s challenges and successes been in complying with the CMS’ new hospital preventive maintenance regulations? Add a comment below.

About Daniel Penn

For more than 32 years, Daniel Penn Associates LLC has been helping maintenance organizations within industry, healthcare and government efficiently control and organize their workload, plan and address future needs and reduce costs.

Daniel Penn Associates Director of Commercial Operations Steve Mueller provides adept analysis of work and information flow, assesses management and work procedures, costs, and develops staffing and resource models for corporations, financial institutions and health care organizations.

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